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2 Special Controls Guidance Documents Released beginning in 2002 for certain product lines. Identifies the risks associated with specific device types as well as the Agency’s recommendations for addressing them. Relies heavily on the use of standards. =>Aimed at reducing regulatory burden while still ensuring that the risks associated with the device are adequately addressed.

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3 2004 Project Purpose To assess the impact of Special Control Guidance Documents on the 510(k) program.

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17 2004 Comments for Improvement “Update guidance documents on a regular basis.” “Have pre-submission conference calls or meetings.” “Respond to comments and suggestions from industry.” “Verbal communication with the FDA is key. They need to tell us when to use and where to find the documents and standards”.

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22 2004 FDA Reviewer Survey: Results Respondents refer to Class II special control guidances during their reviews for the following reasons: To insure review consistency 41% As a training tool or for background information74% To identify relevant FDA recognized consensus standards100%

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23 2004 FDA Reviewer Survey: Results QUESTION: When encountering a standard that has been cited in a submission, what resources do you use for determining the applicability of the standard to the proposed device?

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24 2004 FDA Reviewer Survey: Results QUESTION: When encountering a standard that has been cited in a submission, how effective are the following resources for determining the applicability of the standard to the proposed device?